Spinal implant system and method

ABSTRACT

A method comprises the steps of: fixing a distal end of a first member of a surgical instrument with tissue, the surgical instrument including a second member having a longitudinal passageway configured for disposal of the first member and being connected with a navigation component such that the distal end is disposable with the passageway at a selected distance from the navigation component, the navigation component being positioned relative to a sensor to communicate a signal representative of an orientation of the first member; removing the second member from the first member; and connecting a third member with the first member along the orientation such that a distal end of the third member is fixed with the tissue. Systems, spinal implants, constructs and instruments are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system and method for treating a spine.

BACKGROUND

Spinal pathologies and disorders such as scoliosis and other curvatureabnormalities, kyphosis, degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, tumor and fracture may resultfrom factors including trauma, disease and degenerative conditionscaused by injury and aging. Spinal disorders typically result insymptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. As part of these surgical treatments, spinalconstructs such as vertebral rods are often used to provide stability toa treated region. Rods redirect stresses away from a damaged ordefective region while healing takes place to restore proper alignmentand generally support vertebral members. During surgical treatment, oneor more rods and bone fasteners can be delivered to a surgical site. Therods may be attached via the fasteners to the exterior of two or morevertebral members. Surgical treatment may employ surgical instrumentsand implants that are manipulated for engagement with vertebrae toposition and align one or more vertebrae. This disclosure describes animprovement over these prior technologies.

SUMMARY

In one embodiment, a method for treating a spine is provided. The methodcomprises the steps of: fixing a distal end of a first member of asurgical instrument with tissue, the surgical instrument including asecond member having a longitudinal passageway configured for disposalof the first member and being connected with a navigation component suchthat the distal end is disposable with the passageway at a selecteddistance from the navigation component, the navigation component beingpositioned relative to a sensor to communicate a signal representativeof an orientation of the first member; removing the second member fromthe first member; and connecting a third member with the first memberalong the orientation such that a distal end of the third member isfixed with the tissue. Systems, spinal implants, constructs andinstruments are disclosed.

In one embodiment, the method comprises the steps of: fixing an anchorextending between a proximal end and a distal end with tissue; disposingthe anchor with a longitudinal passageway of a dilator being connectedwith a navigation component such that the distal end is disposable withthe passageway at a selected distance from the navigation component;positioning the navigation component relative to a sensor to communicatea signal representative of an orientation of the anchor; and mounting adrill guide with the anchor along the orientation such that a distal endof the drill guide is engageable with the tissue.

In one embodiment, the method comprises the steps of: fixing an anchorextending between a proximal end and a distal end with tissue; disposingthe anchor with a longitudinal passageway of a dilator being connectedwith a navigation component such that the distal end is disposable withthe passageway at a selected distance from the navigation component;positioning the navigation component relative to a sensor to communicatea signal representative of an orientation of the anchor; mounting adrill guide with the anchor along the orientation such that a distal endof the drill guide is engageable with the tissue; and connecting ananchor tool with the anchor to adjust a depth of the anchor relative totissue and the navigation component.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a perspective view of components of the surgical system shownin FIG. 1 ;

FIG. 3 is a perspective view of components of the surgical system shownin FIG. 1 ;

FIG. 4 is a cross section view of the components shown in FIG. 3 ;

FIG. 5 is a perspective view of components of the surgical system shownin FIG. 1 ;

FIG. 6 is a perspective view of the components shown in FIG. 5 withparts separated;

FIG. 7 is a cross section view of the components shown in FIG. 5 ;

FIG. 8 is a cross section view of the components shown in FIG. 5 ;

FIG. 9 is a cross section view of the components shown in FIG. 5 ;

FIG. 10 is a perspective view of components of the surgical system shownin FIG. 1 ;

FIG. 11 is a cross section view of components of the surgical systemshown in FIG. 1 ;

FIG. 12 is a cross section view of components of the surgical systemshown in FIG. 1 ;

FIG. 13 is a perspective view of components of one embodiment of asurgical system with parts separated in accordance with the principlesof the present disclosure;

FIG. 14 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 15 is a perspective view of detail A shown in FIG. 14 ;

FIG. 16 is a perspective view of detail B shown in FIG. 14 ;

FIG. 17 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 18 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 19 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 20 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 21 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure; and

FIG. 22 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure.

DETAILED DESCRIPTION

The exemplary embodiments of the surgical system and related methods ofuse disclosed are discussed in terms of medical devices for thetreatment of musculoskeletal disorders and more particularly, in termsof a spinal implant system and a method for treating a spine. In someembodiments, the systems and methods of the present disclosure comprisemedical devices including surgical instruments and implants that areemployed with a surgical treatment, as described herein, for example,with a cervical, thoracic, lumbar and/or sacral region of a spine.

In some embodiments, the present surgical system comprises a surgicalinstrument including an anchor and a dilator configured for engagementwith bone utilizing navigation. In some embodiments, the surgicalinstrument is configured to guide a drill guide along the anchor tofacilitate engagement of the drill guide with bone. In some embodiments,the surgical system includes a navigated cannulated dilator, an anchorand an anchor tool. In some embodiments, the anchor is disposed with thedilator and engaged with bone. In some embodiments, the anchor is tampedinto bone and the dilator is removed. In some embodiments, the anchor isengaged with bone utilizing navigation. In some embodiments, a drillguide is guided over the anchor and tamped into bone. In someembodiments, the anchor is removable. See, for example, the embodimentsand disclosure of systems and surgical instruments for engaging boneutilizing surgical navigation, shown and described in commonly owned andassigned U.S. patent application Ser. No. 16/752,557 filed Jan. 24,2020, and published as U.S. Patent Application Publication No.2021-0228280 A1, on Jul. 29, 2021, the entire contents of which beingincorporated herein by reference.

In some embodiments, the present surgical system comprises a surgicalinstrument including the anchor and the dilator being configured toconfirm a trajectory when tamping the drill guide. In some embodiments,the drill guide is engaged with bone utilizing navigation. In someembodiments, the anchor is disposed with the dilator and the dilator isconnected with a navigation component.

In some embodiments, the present surgical system comprises a surgicalinstrument including a disposable anchor. In some embodiments, theanchor includes a groove disposed at a proximal end. In someembodiments, the present surgical system comprises an anchor tool havinga depressible button to connect and lock the anchor with the anchortool. In some embodiments, the anchor tool includes a depth settingdevice.

In some embodiments, the present surgical system comprises a surgicalinstrument including a navigation component that is connected with thedilator and the anchor is inserted through the dilator. In someembodiments, a distal tip of the anchor extends beyond a distal end ofthe dilator. In some embodiments, the distal tip extends a distance fromthe dilator. In some embodiments, the distance the distal tip extends isequal to a length programmed into the navigation system and is utilizedto calculate depth navigation. In some embodiments, the depth settingdevice maintains extension of the distal tip from the dilator.

In some embodiments, the present surgical system includes a method oftreating a spine including the step of inserting the surgical instrumentthrough a cannula to a surgical site. In some embodiments, the methodincludes the step of driving or malleting the anchor tool toprovisionally engage the distal tip of the anchor into bone. In someembodiments, the method includes the step of translating the depthsetting device to a retracted position to allow for driving the anchordeeper once the trajectory has been set and then malleting the anchor toa selected depth. In some embodiments, the method includes the step ofactuating the button to disengage the anchor tool from the anchor andremoving the dilator. In some embodiments, the method includes the stepsof mounting a drill guide over the anchor and malleting the drill guideinto bone. In some embodiments, the method includes the step ofreconnecting the anchor tool with the anchor and using a slap hammer toremove the anchor from bone. In some embodiments, a drill is disposedwith the drill guide and utilized to implant spinal implants.

In some embodiments, the present surgical system comprises a surgicalinstrument including a straight anchor having a pointed distal tip. Insome embodiments, the anchor includes a groove at the proximal end tofacilitate connection with the anchor tool. In some embodiments, thesurgical instrument includes a cannulated dilator. In some embodiments,the dilator includes a tapered distal tip. In some embodiments, thedilator includes a passageway formed by slots milled from each sidealong the dilator.

In some embodiments, the present surgical system comprises a surgicalinstrument including an anchor tool having a depth setting device, ananchor retention button and a slap hammer. In some embodiments, thedepth setting device is disposable in a fully extended position to setthe depth of the anchor for navigation. In some embodiments, pinsconnect the depth setting device with the anchor tool in a keyedconfiguration. In some embodiments, the button is biased outwards by aspring. In some embodiments, the button is engageable with the groove onthe anchor to fix the anchor tool with the anchor. In some embodiments,the slap hammer is moveable to facilitate removing the anchor from bone.

In some embodiments, the present surgical system comprises a surgicalinstrument including a depth setting device being moveable between aretracted position and an extended position. In some embodiments, in theretracted position, a spring tab locks the depth setting device. In someembodiments, the anchor tool includes pins to retain the button with abody of the anchor tool. In some embodiments, a flange is welded withthe anchor tool after the slap hammer is assembled. In some embodiments,a proximal end of the anchor tool is hollow to reduce a weight of theanchor tool.

In some embodiments, the present system is employed with a method usedwith surgical navigation, for example, fluoroscope or image guidance. Insome embodiments, the presently disclosed system and/or method reduceoperating time for a surgical procedure and reduce radiation exposuredue to fluoroscope or image guidance, for example, by eliminatingprocedural steps and patient repositioning by implanting systemcomponents in one body position.

In some embodiments, the surgical system of the present disclosure maybe employed to treat spinal disorders such as, for example, degenerativedisc disease, disc herniation, osteoporosis, spondylolisthesis,stenosis, scoliosis and other curvature abnormalities, kyphosis, tumorand fractures. In some embodiments, the surgical system of the presentdisclosure may be employed with other osteal and bone relatedapplications, including those associated with diagnostics andtherapeutics. In some embodiments, the disclosed surgical system may bealternatively employed in a surgical treatment with a patient in a proneor supine position, and/or employ various surgical approaches to thespine, including anterior, posterior, posterior mid-line, directlateral, postero-lateral, and/or antero-lateral approaches, and in otherbody regions. The surgical system of the present disclosure may also bealternatively employed with procedures for treating the lumbar,cervical, thoracic, sacral and pelvic regions of a spinal column. Thesurgical system of the present disclosure may also be used on animals,bone models and other non-living substrates, such as, for example, intraining, testing and demonstration.

The surgical system of the present disclosure may be understood morereadily by reference to the following detailed description of theembodiments taken in connection with the accompanying drawing figures,which form a part of this disclosure. It is to be understood that thisapplication is not limited to the specific devices, methods, conditionsor parameters described and/or shown herein, and that the terminologyused herein is for the purpose of describing particular embodiments byway of example only and is not intended to be limiting. In someembodiments, as used in the specification and including the appendedclaims, the singular forms “a,” “an,” and “the” include the plural, andreference to a particular numerical value includes at least thatparticular value, unless the context clearly dictates otherwise. Rangesmay be expressed herein as from “about” or “approximately” oneparticular value and/or to “about” or “approximately” another particularvalue. When such a range is expressed, another embodiment includes fromthe one particular value and/or to the other particular value.Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. It is also understood that all spatialreferences, such as, for example, horizontal, vertical, top, upper,lower, bottom, left and right, are for illustrative purposes only andcan be varied within the scope of the disclosure. For example, thereferences “upper” and “lower” are relative and used only in the contextto the other, and are not necessarily “superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. In some embodiments, as used inthe specification and including the appended claims, the term “tissue”includes soft tissue, ligaments, tendons, cartilage and/or bone unlessspecifically referred to otherwise.

The following discussion includes a description of a surgical systemincluding a surgical instrument, related components and methods ofemploying the surgical system in accordance with the principles of thepresent disclosure. Alternate embodiments are also disclosed. Referenceis made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningto FIGS. 1-12 , there are illustrated components of a surgical system,such as, for example, a spinal implant system 10.

The components of spinal implant system 10 can be fabricated frombiologically acceptable materials suitable for medical applications,including metals, synthetic polymers, ceramics and bone material and/ortheir composites. For example, the components of spinal implant system10, individually or collectively, can be fabricated from materials suchas stainless steel alloys, aluminum, commercially pure titanium,titanium alloys, Grade 5 titanium, super-elastic titanium alloys,cobalt-chrome alloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL®), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polypeptide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

Various components of spinal implant system 10 may have materialcomposites, including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of spinal implant system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of spinal implant system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Spinal implant system 10 is employed, for example, with a fully opensurgical procedure, a minimally invasive procedure includingpercutaneous techniques, and mini-open surgical techniques to deliverand introduce instrumentation and/or a spinal implant, for example, abone fastener, at a surgical site of a patient, which includes, forexample, a spine. In some embodiments, the spinal implant can includeone or more components of one or more spinal constructs, such as, forexample, interbody devices, interbody cages, bone fasteners, spinalrods, tethers, connectors, plates and/or bone graft, and can be employedwith various surgical procedures including surgical treatment of acervical, thoracic, lumbar and/or sacral region of a spine.

Spinal implant system 10 includes a surgical instrument 12. Surgicalinstrument 12 can be employed with an end effector 200, as shown in FIG.1 , to facilitate implantation with a robotic arm R (FIG. 22 ). Surgicalinstrument 12 is guided through end effector 200 for guide-wirelessinsertion of a spinal implant, for example, a bone fastener 100, asdescribed herein.

Surgical instrument 12 includes a member, for example, an anchor 14.Anchor 14 extends between a proximal end 16 and a distal end 18, asshown in FIG. 2 . Proximal end 16 includes a surface 20 that defines agroove 22. In some embodiments, groove 22 is disposed circumferentiallyabout end 16. Groove 22 is configured for disposal of a portion of amember, for example, an anchor tool 24 to releasably fix anchor tool 24with anchor 14, as described herein.

End 18 includes a tip 26. In some embodiments, tip 26 is pointed orsharpened to facilitate penetration of tissue. In some embodiments, end18 may have various surface configurations, for example, smooth, rough,arcuate, undulating, porous, semi-porous, dimpled, polished and/ortextured. Tip 26 is configured to fix anchor 14 with tissue to providean orientation, for example, an axial trajectory for the components ofsurgical instrument 12, as described herein.

Surgical instrument 12 includes a member, for example, a dilator 30, asshown in FIGS. 3 and 4 . Dilator 30 extends between a proximal end 32and a distal end 34. Dilator 30 defines a longitudinal axis X1. In someembodiments, dilator 30 may have various configurations including, forexample, round, oval, polygonal, irregular, consistent, variable,uniform and non-uniform. Dilator 30 includes a surface 36 that defines alongitudinal passageway 38 extending between ends 32, 34. In someembodiments, passageway 38 is manufactured by milling overlapping slots40 through surface 36 along dilator 30, as shown in FIG. 4 .

End 34 includes a tapered configuration to facilitate spacing of tissue.In some embodiments, end 34 may have various cross sectionconfigurations, such as, for example, oval, oblong, triangular,rectangular, square, polygonal, irregular, uniform, non-uniform,variable and/or tubular.

Dilator 30 includes a mating element, for example, a bushing 42. Bushing42 is configured to connect a navigation component 280 with surgicalinstrument 12. Bushing 42 includes a flange 44 and a flange 46 that isspaced apart from flange 44. Bushing 42 includes a recess 48 betweenflanges 44, 46. Bushing 42 is disposed with dilator 30. Dilator 30includes mating surfaces, for example, datum surfaces 130. Surface 130is disposed on shaft dilator 30 at a selected distance from distal end34. Surface 130 is detectable by image guidance and utilized todetermine a position of navigation component 280, as described herein,and/or surgical instrument 12 during a surgical procedure. Surface 130is configured for connection with a portion of navigation component 280to facilitate positioning and/or tracking of navigation component 280and/or surgical instrument 12 during a surgical procedure. In someembodiments, dilator 30 may include one or a plurality of matingsurfaces, as described herein.

Navigation component 280, as shown in FIG. 1 , includes a collar 282having an inner surface 284 and an outer surface 286. Surface 284defines a passageway 288. Surface 284 is configured for releasableengagement with bushing 250. Passageway 288 is configured to receivedilator 30 and a portion of bushing 42. Collar 282 includes a lock, forexample, a resilient prong or tab 290. Navigation component 280 isconnected with bushing 42 by tab 290. In some embodiments, collar 282may include one or a plurality of locks, as described herein.

Passageway 38 is configured for disposal of anchor 14, as describedherein. Dilator 30 is removably mounted with anchor 14 such that tip 26is positioned at a selected distance from navigation component 280.Navigation component 280 is positioned relative to a sensor tocommunicate a signal representative of the orientation of anchor 14during engagement with tissue. Tip 26 is configured to fix anchor 14with tissue to provide the axial trajectory for the components ofsurgical instrument 12, as described herein.

Anchor tool 24 includes a body 50. Body 50 extends between an end 52 andan end 54. End 54 includes slots 56 and spring tabs 58, as shown in FIG.6 . Anchor tool 24 includes a part, for example, a depth setter 60 and abutton 62, as shown in FIGS. 5-9 .

Depth setter 60 includes a slider 64 and a sleeve 66. Sleeve 66 includesa surface 70 configured for engagement with spring tabs 58 in a frictionfit configuration to fix sleeve 66 in the extended position, as shown inFIG. 7 and/or the retracted position, as shown in FIG. 8 . In someembodiments, sleeve 66 and body 50 may be disposed with an integralconnection, friction fit, pressure fit, interlocking engagement, matingengagement, dovetail connection, clips, barbs, tongue in groove,threaded, magnetic and/or key/keyslot. Sleeve 66 includes a surface thatdefines a channel 72. Channel 72 is disposed in communication with achannel 74 of body 50, as shown in FIG. 7 . Channels 72, 74 areconfigured for disposal of anchor 14, as described herein.

Pins 68 extend through slots 56 to connect slider 64 and sleeve 66 withbody 50, as shown in FIGS. 7 and 8 , such that translation of slider 64causes translation of sleeve 66 between an extended position and aretracted position relative to body 50.

For example, translation of slider 64, in a direction shown by arrow A1in FIG. 7 , causes sleeve 66 to simultaneously translate via connectionof pins 68, in a direction shown by arrow A1 in FIG. 7 , to the extendedposition. In the extended position, sleeve 66 is disposed in an abuttingengagement with collar 282 of navigation component 280, as shown in FIG.13 . In the extended position, sleeve 66 positions the extension and/ordepth of tip 26 beyond end 34 a selected distance from navigationcomponent 280. Sleeve 66 resists and/or prevents extension of tip 26further than the selected distance. Tip 26 is provisionally fixed withtissue under navigation by communication of navigation component 280with a surgical navigation system 306, as described herein.

Translation of slider 64 in the opposite direction, in a direction shownby arrow A2 in FIG. 8 , causes sleeve 66 to simultaneously translate, inthe direction shown by arrow A2 in FIG. 8 , to the retracted position.In the retracted position, sleeve 66 is spaced a distance from collar282, as shown in FIG. 15 , to allow anchor 14 to translate throughdilator 30 to extend further from end 34 of dilator 30 to facilitatedriving anchor 14 a further depth into tissue for docking.

Button 62 is connected with body 50 by pins 80. Button 62 includes aprotrusion 82 having a surface 84 that defines an opening 86. Opening 86is configured for disposal of anchor 14 and surface 84 is configured toengage groove 22 to fix anchor 14 with anchor tool 24. Button 62 isbiased to a closed position by springs 88 such that protrusion 82 blockschannel 74. To capture anchor 14, a force is applied to button 62, in adirection shown by arrow C in FIG. 8 , causing opening 86 to align withchannel 74 to allow anchor 14 to translate therethrough. Button 62 isreleased and the bias of springs 88 pushes button 62, in a directionshown by arrow D in FIG. 8 , causing surface 84 to engage surface 20 ofgroove 22 to capture anchor 14. To release anchor 14, a force is appliedto button 62, in the direction shown by arrow C in FIG. 8 , causingsurface 84 to disengage surface 20 of groove 22 to release anchor 14.Opening 86 aligns with channel 74 to allow anchor 14 to translatetherethrough for disengagement from anchor tool 24.

In some embodiments, anchor tool 24 includes a handle portion 90 thatincludes a flange 92, a slap hammer 94 and an end flange 96. Slap hammer94 translates between flange 92 and end flange 96 to facilitate removinganchor 14 from the surgical site. In some embodiments, handle portion 90is hollow to reduce the weight of anchor tool 24.

Surgical instrument 12 includes a member, for example, a drill guide100, as shown in FIGS. 20 and 21 . Drill guide 100 extends between aproximal end 102 and a distal end 104. Distal end 104 is configured toengage tissue. Drill guide 100 includes a surface 106 that defines apassageway 108 configured for disposal of a drill. Drill guide 100 isutilized to assist in control and guidance of a surgical drill. Drillguide 100 is securely docked by mounting drill guide 100 with anchor 14.Anchor 14 guides drill guide 100 along the axial trajectory to engagedistal end 104 of drill guide 100 with bone.

In assembly, operation and use, as shown in FIGS. 13-22 , spinal implantsystem 10, similar to the systems and methods described herein, isemployed with a surgical procedure, for example, a treatment of anapplicable condition or injury of an affected section of a spinal columnand adjacent areas within a body. In some embodiments, one or all of thecomponents of spinal implant system 10 can be delivered or utilized as apre-assembled device or can be assembled in situ. Spinal implant system10 may be completely or partially revised, removed or replaced.

In some embodiments, a scalpel (not shown) is oriented for disposal withend effector 200 of robotic arm R, as described herein. An incision ismade in the skin S1 of a patient with the scalpel, which creates asurgical pathway for implantation of components of spinal implant system10. A speculum (not shown) can be employed to assist in creating thesurgical pathway. A preparation instrument (not shown) can be employedto prepare tissue surfaces as well as for aspiration and irrigation of asurgical region. A cannula 150 is inserted into end effector 200 and isinserted into the surgical pathway. Surgical instrument 12 is assembled.Anchor 14 is disposed with passageway 38 of dilator 30. Navigationcomponent 280 is connected with dilator 30. Navigation component 280 istranslated along dilator 30 into a mating engagement with surface 130and connected with bushing 42 by tab 290.

Anchor tool 24 is connected with anchor 14. Anchor 14 is translated intochannel 72 and channel 74. Button 62 is actuated causing opening 86 toalign with channel 74 to allow anchor 14 to translate therethrough.Button 62 is released and the bias of springs 88 pushes button 62causing surface 84 to engage surface 20 of groove 22 to capture anchor14.

Slider 64 is translated and causes sleeve 66 to simultaneously translatevia connection of pins 68 into the extended position. In the extendedposition, sleeve 66 is disposed in an abutting engagement with collar282 of navigation component 280, as shown in FIG. 13 . In the extendedposition, sleeve 66 positions the extension and/or depth of tip 26beyond end 34 a selected distance from navigation component 280 andsurface 130. Sleeve 66 resists and/or prevents extension of tip 26further than the selected distance.

Surgical instrument 12 is inserted into cannula 150. Dilator 30 expandsskin S1 along the surgical pathway. Navigation component 280 is orientedrelative to a sensor array 302, as shown in FIG. 22 , to facilitatecommunication between navigation component 280 and sensor array 302during a surgical procedure, as described herein.

Navigation component 280 is configured to generate a signalrepresentative of a position of anchor 14 relative to tissue. In someembodiments, the image guide may include human readable visual indicia,human readable tactile indicia, human readable audible indicia, one ormore components having markers for identification under x-ray,fluoroscopy, CT or other imaging techniques, at least one light emittingdiode, a wireless component, a wired component, a near fieldcommunication component and/or one or more components that generateacoustic signals, magnetic signals, electromagnetic signals and/orradiologic signals.

Navigation component 280 includes an emitter array 304. Emitter array304 is configured for generating a signal to sensor array 302 of asurgical navigation system 306. In some embodiments, the signalgenerated by emitter array 304 represents a position of anchor 14relative to tissue, for example, bone. In some embodiments, the signalgenerated by emitter array 304 represents a three-dimensional positionof anchor 14 relative to tissue.

In some embodiments, sensor array 302 receives signals from emitterarray 304 to provide a three-dimensional spatial position and/or atrajectory of anchor 14 relative to tissue. Emitter array 304communicates with a processor of a computer 308 of surgical navigationsystem 306 to generate data for display of an image on a monitor 310, asdescribed herein. In some embodiments, sensor array 302 receives signalsfrom emitter array 304 to provide a visual representation of a positionof anchor 14 relative to tissue. See, for example, similar surgicalnavigation components and their use as described in U.S. Pat. Nos.6,021,343, 6,725,080, and 6,796,988, the entire contents of each ofthese references being incorporated by reference herein.

Surgical navigation system 306 is configured for acquiring anddisplaying medical imaging, for example, x-ray images appropriate for agiven surgical procedure. In some embodiments, pre-acquired images of apatient are collected. In some embodiments, surgical navigation system306 can include an O-Arm® imaging device 312 sold by MedtronicNavigation, Inc. having a place of business in Louisville, Colo., USA.Imaging device 312 may have a generally annular gantry housing thatencloses an image capturing portion 314.

In some embodiments, image capturing portion 314 may include an x-raysource or emission portion and an x-ray receiving or image receivingportion located generally or as practically possible 180 degrees fromeach other and mounted on a rotor (not shown) relative to a track ofimage capturing portion 314. Image capturing portion 314 can be operableto rotate 360 degrees during image acquisition. Image capturing portion314 may rotate around a central point or axis, allowing image data ofthe patient to be acquired from multiple directions or in multipleplanes. Surgical navigation system 306 can include those disclosed inU.S. Pat. Nos. 8,842,893, 7,188,998; 7,108,421; 7,106,825; 7,001,045;and 6,940,941; the entire contents of each of these references beingincorporated by reference herein.

In some embodiments, surgical navigation system 306 can include C-armfluoroscopic imaging systems, which can generate three-dimensional viewsof a patient. The position of image capturing portion 314 can beprecisely known relative to any other portion of an imaging device ofsurgical navigation system 306. In some embodiments, a precise knowledgeof the position of image capturing portion 314 can be used inconjunction with a tracking system 316 to determine the position ofimage capturing portion 314 and the image data relative to the patient.

Tracking system 316 can include various portions that are associated orincluded with surgical navigation system 306. In some embodiments,tracking system 316 can also include a plurality of types of trackingsystems, such as, for example, an optical tracking system that includesan optical localizer, such as, for example, sensor array 302 and/or anEM tracking system that can include an EM localizer. Various trackingdevices can be tracked with tracking system 316 and the information canbe used by surgical navigation system 306 to allow for a display of aposition of an item, such as, for example, a patient tracking device, animaging device tracking device 320, and an instrument tracking device,such as, for example, emitter array 304, to allow selected portions tobe tracked relative to one another with the appropriate tracking system.

In some embodiments, the EM tracking system can include theSTEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation,Inc. having a place of business in Louisville, Colo. Exemplary trackingsystems are also disclosed in U.S. Pat. Nos. 8,057,407, 5,913,820, and5,592,939, the entire contents of each of these references beingincorporated by reference herein.

Fluoroscopic images taken are transmitted to a computer 318 where theymay be forwarded to computer 308. Image transfer may be performed over astandard video connection or a digital link including wired andwireless. Computer 308 provides the ability to display, via monitor 310,as well as save, digitally manipulate, or print a hard copy of thereceived images. In some embodiments, images may also be displayed tothe surgeon through a heads-up display.

In some embodiments, surgical navigation system 306 provides forreal-time tracking of the position of bone fastener 100 relative tosurgical instrument 12 and/or tissue can be tracked. Sensor array 302 islocated in such a manner to provide a clear line of sight with emitterarray 304, as described herein. In some embodiments, fiducial markers322 of emitter array 304 communicate with sensor array 302 via infraredtechnology. Sensor array 302 is coupled to computer 308, which may beprogrammed with software modules that analyze signals transmitted bysensor array 302 to determine the position of each object in a detectorspace.

Surgical instrument 12 is configured for use with a guide member, forexample, an end effector 200 of robotic arm R to determine axialtrajectory of a surgical pathway and/or facilitate positioning of one ormore surgical instruments, implants and/or components of spinal implantsystem 10 in alignment with the axial trajectory of a surgical pathway.End effector 200 includes an inner surface 202 that defines a cavity,for example, a channel 204. Channel 204 is configured for disposal ofone or more components of surgical instrument 12 and/or implants.Robotic arm R includes position sensors (not shown), similar to thosereferenced herein, which measure, sample, capture and/or identifypositional data points of end effector 200 in three-dimensional spacefor a guide-wireless insertion of surgical instrument 12 with tissue. Insome embodiments, the position sensors of robotic arm R are employed inconnection with surgical navigation system 306 to measure, sample,capture and/or identify positional data points of end effector 200 inconnection with surgical treatment, as described herein. The positionsensors are mounted with robotic arm R and calibrated to measurepositional data points of end effector 200 in three-dimensional space,which are communicated to computer 308.

Tip 26 is provisionally fixed with bone B1 to define an axial trajectoryAT, as shown in FIG. 14 . Axial trajectory AT of anchor 14 is confirmedby communication of navigation component 280 with surgical navigationsystem 306, as described herein.

To dock anchor 14, slider 64 is translated into the retracted position.Translation of slider 64 causes sleeve 66 to simultaneously translateinto the retracted position. In the retracted position, sleeve 66 isspaced a distance from collar 282, as shown in FIG. 15 , to allow anchor14 to translate through dilator 30 to extend further from end 34 ofdilator 30 to drive anchor 14 a greater depth into bone B1 for docking.Anchor 14 is docked with bone B1 along axial trajectory AT.

Anchor tool 24 is removed from anchor 14, as shown in FIG. 17 . Torelease anchor 14, button 62 is actuated to cause surface 84 todisengage surface 20 of groove 22 to release anchor 14. Opening 86aligns with channel 74 to allow anchor 14 to translate therethrough fordisengagement from anchor tool 24. In some embodiments, slap hammer 94is utilized to facilitate releasing anchor 14 from bone B1. Dilator 30is removed from anchor 14, as shown in FIG. 18 .

Drill guide 100 is mounted with anchor 14, as shown in FIG. 19 , suchthat anchor 14 is disposed with passageway 108. Anchor 14 directs and/orguides drill guide 100 along axial trajectory AT through cannula 150.End 104 of drill guide 100 extends from a distal end of cannula 150.Drill guide 100 is tamped along anchor 14 and axial trajectory ATcausing end 104 to engage bone B1. As such, drill guide 100 is dockedwith bone B1 along navigated axial trajectory AT thereby maintaining thealignment and/or trajectory of drill guide 100 during docking.

Anchor 14 is removed from bone B1 by reattaching anchor tool 24. Anchor14 is translated into channel 72 and channel 74. Button 62 is actuatedcausing opening 86 to align with channel 74 to allow anchor 14 totranslate therethrough. Button 62 is released and the bias of springs 88pushes button 62 causing surface 84 to engage surface 20 of groove 22 tocapture anchor 14. In some embodiments, slap hammer 94 is utilized tofacilitate releasing anchor 14 from bone B1. Anchor 14 is removed frombone B1 and the surgical site.

A drill (not shown) is paired with a selected drill bit and insertedinto drill guide 100. Drill guide 100 directs and/or guides the drillalong the axial trajectory AT. In some embodiments, the drill includes anavigation component, similar to navigation component 280 as describedherein. The navigation component is oriented relative to sensor array302 to confirm trajectory by communication of the navigation componentwith surgical navigation system 306, similar to that described herein.Pilot holes (not shown) are made with the selected areas of bone forreceiving spinal implants such as bone fasteners for the surgicalprocedure.

Upon completion of a procedure, as described herein, the surgicalinstruments, assemblies and non-implanted components of spinal implantsystem 10 are removed and the incision(s) are closed. One or more of thecomponents of spinal implant system 10 can be made of radiolucentmaterials such as polymers. Radiomarkers may be included foridentification under x-ray, fluoroscopy, CT or other imaging techniques.In some embodiments, spinal implant system 10 may include one or aplurality of spinal rods, plates, connectors and/or bone fasteners foruse with a single vertebral level or a plurality of vertebral levels.

In some embodiments, one or more bone fasteners, as described herein,may be engaged with tissue in various orientations, such as, forexample, series, parallel, offset, staggered and/or alternate vertebrallevels. In some embodiments, the bone fasteners may comprise multi-axialscrews, sagittal adjusting screws, pedicle screws, mono-axial screws,uni-planar screws, facet screws, fixed screws, tissue penetratingscrews, conventional screws, expanding screws, wedges, anchors, buttons,clips, snaps, friction fittings, compressive fittings, expanding rivets,staples, nails, adhesives, posts, fixation plates and/or posts.

In one embodiment, spinal implant system 10 includes an agent, which maybe disposed, packed, coated or layered within, on or about thecomponents and/or surfaces of spinal implant system 10. In someembodiments, the agent may include bone growth promoting material, suchas, for example, bone graft to enhance fixation of the components and/orsurfaces of spinal implant system 10 with vertebrae. In someembodiments, the agent may include one or a plurality of therapeuticagents and/or pharmacological agents for release, including sustainedrelease, to treat, for example, pain, inflammation and degeneration.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A method for treating a spine, the methodcomprising the steps of: fixing a distal end of a first member of asurgical instrument with tissue, the surgical instrument including asecond member having a longitudinal passageway configured for disposalof the first member and being connected with a navigation componentbefore connecting the first member with a third member of the surgicalinstrument such that the distal end is disposable with the passageway ata selected distance from the navigation component, the navigationcomponent being positioned relative to a sensor to communicate a signalrepresentative of an orientation of the first member; removing thesecond member from the first member; connecting the third member withthe first member along the orientation such that a distal end of thethird member is fixed with the tissue; and connecting a fourth memberwith the first member to adjust a depth of the first member relative totissue and the navigation component.
 2. A method as recited in claim 1,wherein the distal end of the first member includes a pointed tipconfigured to penetrate tissue.
 3. A method as recited in claim 1,wherein the second member includes a cannulated dilator.
 4. A method asrecited in claim 1, wherein the fourth member includes a lock beingreleasably engageable with the first member.
 5. A method as recited inclaim 4, wherein the lock includes a spring button.
 6. A method asrecited in claim 1, wherein the fourth member includes a part configuredto adjust the depth of the first member relative to tissue and thenavigation component.
 7. A method as recited in claim 6, wherein thepart is translatable to adjust the depth of the first member.
 8. Amethod as recited in claim 6, wherein the part includes a fixationelement configured to fix the part between a first position and a secondposition.
 9. A method as recited in claim 1, wherein the navigationcomponent is not connected to the first member or the third member whenthe third member is connected with the first member.
 10. A method asrecited in claim 1, wherein removing the second member from the firstmember comprises removing the navigation component from the firstmember.
 11. A method as recited in claim 1, wherein the third member isconnected with the first member after the second member and navigationcomponent have been removed from the first member.
 12. A method asrecited in claim 1, wherein the distal end is non-threaded.
 13. A methodas recited in claim 1, further comprising an end effector coupled to thethird member when the third member is connected with the first member,the fourth member comprising a proximal end that directly engages aproximal end of the end effector and an opposite distal end that extendsthrough a distal end of the third member.
 14. A method for treating aspine, the method comprising the steps of: fixing an anchor extendingbetween a proximal end and a distal end with tissue; disposing theanchor with a longitudinal passageway of a dilator being connected witha navigation component before the anchor is connected with a drill guidesuch that the distal end is disposable with the passageway at a selecteddistance from the navigation component; positioning the navigationcomponent relative to a sensor to communicate a signal representative ofan orientation of the anchor; and mounting the drill guide with theanchor along the orientation after removing the dilator and thenavigation component from the anchor such that a distal end of the drillguide is engageable with the tissue.
 15. A method as recited in claim14, wherein the orientation includes an axial trajectory of the anchorrelative to tissue.
 16. A method as recited in claim 14, furthercomprising the step of guiding the drill guide with the anchor along theaxial trajectory for engagement with tissue.
 17. A method for treating aspine, the method comprising the steps of: fixing an anchor extendingbetween a proximal end and a distal end with tissue; disposing theanchor with a longitudinal passageway of a dilator being connected witha navigation component before the anchor is connected with a drill guidesuch that the distal end is disposable with the passageway at a selecteddistance from the navigation component; positioning the navigationcomponent relative to a sensor to communicate a signal representative ofan orientation of the anchor; mounting the drill guide with the anchoralong the orientation after removing the dilator and the navigationcomponent from the anchor such that a distal end of the drill guide isengageable with the tissue; and connecting an anchor tool with theanchor to adjust a depth of the anchor relative to tissue and thenavigation component.
 18. A method as recited in claim 17, wherein theorientation includes an axial trajectory of the anchor relative totissue.
 19. A method as recited in claim 17, further comprising the stepof guiding the drill guide with the anchor along the axial trajectoryfor engagement with tissue.